Systems and methods for ligament graft preparation

ABSTRACT

Systems and methods for preparing a ligament graft for a ligament reconstruction procedure are provided. In general, the described techniques utilize a graft preparation system having a holder and a delivery suture assembly removably coupled thereto. The delivery suture assembly can include a spine coupled with an anchor suture configured to form a self-tightening knot used to position the assembly around a graft and a plurality of suture windings configured to be affixed to the graft when the assembly is deployed. The assembly is delivered to the graft using the holder and the sutures can be affixed to the graft without penetrating therethrough. The spine helps to evenly distribute the load among the windings compressing the graft which are thus are capable of withstanding increased loads. Thus, an improved, simplified, and time- and labor-saving approach to preparing ligament grafts is provided.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/994,000 entitled “Systems and Methods for Ligament GraftPreparation” filed May 31, 2018, which is a continuation of U.S. patentapplication Ser. No. 14/327,358 (now U.S. Pat. No. 9,993,332) filed Jul.9, 2014 and entitled “Systems and Methods for Ligament GraftPreparation” which are hereby incorporated by reference in its entirety.

FIELD

The present invention relates to systems and methods for preparingligament grafts.

BACKGROUND

A ligament is a piece of fibrous tissue which connects one bone toanother within the body. Ligaments are frequently damaged (e.g.,detached, torn or ruptured) as the result of injury or accident. Adamaged ligament can impede proper motion of a joint and causesignificant pain. A damaged ligament can be replaced or repaired usingvarious procedures, a choice of which can depend on a particularligament to be restored and on the extent of the damage. When ligamentsare damaged, surgical reconstruction can be necessary, as the ligamentsmay not regenerate on their own.

An example of a ligament that is frequently damaged as a result ofinjury, overexertion, aging and/or accident is the anterior cruciateligament (ACL) that extends between a top of the tibia and a bottom ofthe femur. A damaged ACL can cause instability of the knee joint,arthritis, and substantial pain.

ACL repair typically includes the use of a ligament graft replacementprocedure which usually involves drilling a bone tunnel through thetibia and up into the femur. Then a ligament graft, which may be anartificial ligament or harvested graft, such as a tendon, is passedthrough a tibial portion of the tunnel (sometimes referred to as “thetibial tunnel”) across the interior of the joint, and up into a femoralportion of a tunnel (sometimes referred to as “the femoral tunnel”). Oneend of the ligament graft can then be secured in the femoral tunnel andanother end of the graft is secured in the tibial tunnel, at the siteswhere the natural ligament attaches.

Another ligament that is often damaged and may need to be replaced is aposterior cruciate ligament (PCL).

A common ligament reconstruction procedure involves using an autograft,which is a patient's own tendon that would replace the damaged naturalligament. The autograft is often a hamstring tendon, though othertendons can be used (e.g., a patellar tendon). The ligament graft canalso be obtained from a donor (“allograft”).

Ligament augmentation and replacement procedures typically requirepreparation of a harvested ligament graft using various techniques tosecure the graft for passing through the drilled tunnels and tostrengthen the graft prior to fixation. The preparation may involvecleaning and measuring the graft, and then affixing sutures to free endsthereof. The thus prepared graft can be tensioned prior to beinginserted into the femoral and tibial tunnels.

FIG. 1 illustrates an example of a graft 100 prepared using aconventional whip-stitching (simple or locking) technique. A needle (notshown) or other suture passing instrument can be used to pass a suture102 through the graft 100 to create stitches some of which are labeledas 102A and 102B in FIG. 1. The whip-stitching can have certaindrawbacks. For example, it may cause trauma to the graft and undesirableexcessive elongation of the graft when a load is applied thereto. Thiscan compromise the quality of the graft 100 and create a risk ofcomplications during the ligament reconstruction procedure.

Other existing graft preparation techniques include, for example,baseball stitching, roman sandal suture techniques, krackow and Prusikknots.

The conventional approaches to graft preparation, such as thewhip-stitching technique described above, can be labor- andtime-consuming and may take up a large portion of time during areconstruction surgery. Placing a suture on the graft can be cumbersomeand, when a graft is prepared using such techniques, the entirereconstruction procedure may be put on hold, which can contribute toincreased costs of the surgery. In addition, the surgeon or othermedical personnel sewing the stitches bears a risk of a needle-stickinjury which can lead to potential infections.

Accordingly, there is a need for improved techniques for preparinggrafts.

SUMMARY

A graft preparation system is provided that in some embodiments cancomprise a spine having first and second ends, a plurality of windingsformed from a first suture and spaced longitudinally along the spine,each winding being coupled to the spine by passing the first suturethrough attachment elements longitudinally spaced along the spine, and asecond, anchor suture configured to position the spine and the pluralityof windings coupled thereto around a graft, the anchor suture beingcoupled to the spine by passing through at least one of the attachmentelements adjacent to the first end of the spine.

The graft preparation system can vary in any number of ways. Forexample, at least one of the attachment elements can comprise an eyeletformed in the spine. The eyelet may be formed integrally with the spine.The graft preparation system may further comprise an elongate holderhaving a first surface and a second surface and it may be configured toreceive the graft adjacent the second surface thereof. The spine can beremovably positioned along the first surface of the elongate holder. Insome embodiments, at least one element selected from the spine, theplurality of windings, and the anchor suture can be removably coupledwith the holder.

The elongate holder can have any number of variations. For example, theelongate holder can have a configuration that can be changed to separatethe spine from the elongate holder. In some embodiments, the elongateholder can be substantially cylindrical in shape and the second surfacecan be an inner surface. In other embodiments, the elongate holder cancomprise a substantially rectangular element and the second surface canbe an inner surface. The holder can have any suitable size and shape.

In some embodiments, windings from the plurality of windings can form acriss-crossing pattern along a surface of the elongate holder. In someembodiments, windings from the plurality of windings include first andsecond tails extending from the second end of the spine opposite to thefirst end of spine being coupled to the anchor suture.

The anchor suture can vary in any number of ways. For example, theanchor suture can be configured to form a collapsible loop surroundingthe holder and can be selectively removable therefrom. In someembodiments, the anchor suture may be configured to form a snarecomprising a self-tightening knot. The anchor suture can be formedintegrally with the spine. In some embodiments, the anchor suture can beconfigured to penetrate through the graft.

In another aspect, a method of preparing a graft for a surgicalprocedure is provided that in some embodiments comprises positioning agraft preparation system around a portion of the graft, the graftpreparation system comprising a holder and a delivery suture assemblycomprising a spine positioned along a first surface of the holder, aplurality of windings that are spaced longitudinally along the spinesuch that the windings are coupled to the spine, and a second, anchorsuture coupled to the spine. The method can also comprise separating theholder from the portion of the graft such that the delivery sutureassembly remains positioned around the portion of the graft and theholder is removed, manipulating the anchor suture to affix the deliverysuture assembly adjacent a first end of the portion of the graft withoutpenetrating the graft, and, after the delivery suture assembly isaffixed around the first end of the portion of the graft, manipulatingat least one suture tail of the windings to secure the plurality ofwindings around the portion of the graft without penetrating the graftsuch that the windings are spaced apart along a length of the portion ofthe graft.

The method can vary in any number of ways. For example, following thepositioning of the graft preparation system, the windings and the anchorsuture can form loose loops around the portion of the graft.Manipulating the anchor suture can comprise pulling a tail of the anchorsuture in a first direction, and manipulating the at least one suturetail of the windings can comprise pulling first and second tails of theat least one suture tail in an opposite, second direction to tighten theloops upon the graft. The anchor suture can be secured to the portion ofthe graft with a self-locking snare.

In another aspect, a method of preparing a graft for a surgicalprocedure is provided that in some embodiments comprises positioning adelivery suture assembly around a portion of the graft, the deliverysuture assembly comprising a spine, a plurality of windings that arespaced longitudinally along the spine such that the windings are coupledto the spine, and a second, anchor suture coupled to the spine. Themethod can also comprise pulling a tail end of the anchor suture in afirst direction to affix the delivery suture assembly adjacent a firstend of the portion of the graft without penetrating the graft; and afterthe delivery suture assembly is affixed around the first end of theportion of the graft, pulling at least one suture tail of the windingsto secure the plurality of windings around the portion of the graftwithout penetrating the graft such that the windings are spaced apartalong a length of the portion of the graft.

The method can vary in any number of ways. For example, the deliverysuture assembly can be positioned around the portion of the graft usinga holder member having the delivery suture assembly removably associatedtherewith. The method can further comprise separating the deliverysuture assembly positioned around the portion of the graft from theholder member such that the delivery suture assembly remains positionedaround the portion of the graft and the holder member is removed. Insome embodiments, separating the delivery suture assembly from theholder member may comprise changing a configuration of the holdermember. The anchor suture can be secured to the portion of the graftwith a self-locking snare.

In yet another aspect, a graft preparation assembly is provided that insome embodiments may comprise a spine having first and second ends and aplurality of windings formed from a first suture and spacedlongitudinally along the spine, each winding being coupled to the spineby passing the first suture through attachment elements associated withthe spine. The spine and the plurality of windings can be configured toreceive a graft such that the windings are positioned around the graft.The plurality of windings may be associated with the spine by beinglongitudinally spaced along the spine. The graft preparation assemblymay vary in a number of ways. For example, the graft preparationassembly may further include an anchoring element, which may be aseparate suture or other element, or may be an extension of the spine.In some embodiments, the first suture may also be an extension of thespine.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments described above will be more fully understood from thefollowing detailed description taken in conjunction with theaccompanying drawings. The drawings are not intended to be drawn toscale. For purposes of clarity, not every component may be labeled inevery drawing. In the drawings:

FIG. 1 (Prior Art) is a schematic illustration of a graft prepared usingwhip-stitching;

FIG. 2 is a schematic illustration of a graft preparation system inaccordance with some embodiments;

FIGS. 3A-3E are schematic illustrations of steps of making a graftpreparation system in accordance with some embodiments;

FIGS. 3F-3M are schematic illustrations of steps of making a graftpreparation system in accordance with other embodiments;

FIGS. 4A and 4B are alternative views of the graft preparation system inaccordance with some embodiments;

FIG. 5 is a schematic illustration of a graft;

FIG. 6A is a schematic illustration of the graft preparation system inaccordance with some embodiments;

FIGS. 6B-6E are schematic illustrations of steps of preparing the graftof FIG. 5 using the graft preparation system of FIG. 6A;

FIGS. 7A-7H are additional illustrations of steps of preparing a graftusing a graft preparation system in accordance with some embodiments;

FIGS. 8A-8C are schematic illustrations of a graft preparation systemincluding a card holder, in accordance with some embodiments;

FIG. 9 is a schematic illustration of an embodiment where a deliverysuture assembly in accordance with some embodiments is provided to agraft without employing a holder;

FIGS. 10A-10C are schematic illustrations of employing a graftpreparation system including a holder having an alternativeconfiguration, in accordance with some embodiments;

FIG. 11 is a schematic illustration of a graft prepared in accordancewith some embodiments; and

FIG. 12 is a schematic illustration of a graft preparation systemincluding an anchoring element that can penetrate through a graft, inaccordance with some embodiments.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the systems and methodsdisclosed herein. One or more examples of these embodiments areillustrated in the accompanying drawings. Those skilled in the art willunderstand that the systems and methods specifically described hereinand illustrated in the accompanying drawings are non-limiting exemplaryembodiments and that the scope of the embodiments is defined solely bythe claims. Further, the features illustrated or described in connectionwith one exemplary embodiment may be combined with the features of otherembodiments. Such modifications and variations are intended to beincluded within the scope of the described embodiments.

The embodiments described herein generally relate to systems and methodsfor preparing ligament grafts for ligament reconstruction, oraugmentation, surgeries. In some embodiments, the graft preparationsystem can include a holder and a delivery suture assembly comprising aspine, and an anchor suture and a plurality of suture windings coupledto the spine. The graft preparation system can be made such that it isready to be deployed, which can greatly reduce the time required toaffix sutures to the graft.

The holder can be used to deliver the delivery suture assembly to thegraft, which can then be separated from the holder and affixed to thegraft using a few steps. The anchor suture can include a pre-assembledself-tightening knot and can be used to lock a position of the windingsaround a graft. The spine having the windings coupled thereto helps toevenly distribute the load among the windings when they are deployed. Inthis way, the windings can be used to compress the graft more evenly,without strangulating it, and the suture can withstand increased loads.As a result, the strength of fixation of a delivery suture assembly tothe graft can be improved.

Accordingly, the systems and methods described herein may have a numberof advantages over existing techniques for preparing ligament grafts. Inparticular, the entire graft preparation procedure can bestraightforward and requires a surgeon to take only a few quick steps toaffix the delivery suture assembly to the graft. A need forwhip-stitching or any other technique requiring penetrating the graftmay be avoided. As a result, a risk of causing trauma to the graft canbe reduced and a time required to prepare the graft can be significantlyreduced, which can facilitate the surgery and mitigate inconvenience tothe patient. Because a pre-assembled construct is utilized, thereproducibility of the procedure is improved. Thus, the described graftpreparation procedure is simplified and is less labor-intensive, whichimproves efficiency of the ligament reconstruction procedure, andmitigates risks posed by conventional time-consuming and less reliablegraft preparation techniques. In addition, the described techniques canhelp to save operating room costs.

The described techniques can be used in conjunction with a variety ofligament grafts, including hamstring ligament grafts, in a variety ofdifferent surgical contexts regardless of the type of ligament graftbeing used in a particular surgical procedure. The systems and methodsdescribed herein can be utilized in connection with preparing graftligaments for repairing or replacing ligaments in a variety of joints,but can in some embodiments have particular utility in cruciate ligamentreconstruction procedures. In some embodiments, the systems and methodsdescribed herein can be utilized for preparing ligament grafts forreconstruction procedures such as, for example, the cruciate ligamentsof the knee.

FIG. 2 shows a graft preparation system 200 in accordance with someembodiments. The graft preparation system 200 can be pre-assembled andcan be efficiently utilized by a medical professional to deliver suturesto a graft during a ligament reconstruction procedure withoutpenetrating through the graft.

The graft preparation system 200 can include a holder 202 removablycarrying a delivery suture assembly 204. The delivery suture assembly204 can include a spine 206, an anchor suture 208 and a plurality ofwindings 210, individually labeled as windings 210A-210G which areformed from a suture 212 having tails 214A and 214B. As illustrated, theanchor suture 208 and the windings 210 are coupled to the spine 206.

The holder 202 can have any suitable configuration that allowsseparating the delivery suture assembly 204 therefrom. In FIG. 2, theholder 202 is an elongate member having a first, outer surface 217, anda second, inner surface 218. The outer surface 217 can have the deliverysuture assembly 204 associated therewith, and the inner surface 218 canbe configured to receive a graft when the graft preparation system 200is deployed to affix sutures 208, 212 to the graft.

In the example of FIG. 2, the elongate holder 202 is substantiallycylindrical in shape. As used herein, “substantially cylindrical” meansgenerally having the shape of a cylinder, either with or without acontour, which can be an open or closed cylinder. However, it should beappreciated that the substantially cylindrical holder 202 is shown byway of example only, and a holder carrying a delivery suture assembly inaccordance with embodiments described herein can have any suitableconfiguration. For example, the holder can be a foldable and/orcollapsible element, for example, a card shown in FIGS. 8A-8C, a wirecage or other suitable element. The holder can also be a componenthaving at an end thereof a feature configured to be attached to aligament graft. An example of such a holder can be a surgical grasper(FIG. 9). When the ligament graft is attached to the holder, thedelivery suture assembly may be manipulated to slide off or otherwiseseparate from the holder to thereby be positioned over the graft.

As another example, in some embodiments and discussed below with respectto FIGS. 10A-10C, the holder may comprise an implantable element whichmay be an integral part of the delivery suture assembly such that theentire holder or one or more of its parts are not separated from thedelivery suture assembly upon positioning of the assembly around thegraft. For example, the holder can form the spine such that the spine isa part of the holder. In such cases, the spine can be at least partiallyformed from a plastic or other suitable material that is sufficientlyrigid such that the spine itself can be used to deliver the deliverysuture assembly coupled therewith to the graft. Additionally oralternatively, the holder can be configured such that its surface cancarry the spine and the anchor suture only, or the spine, the anchorsuture positioned at one end of the spine and the winding positioned atthe other, opposite end of the spine. Such configurations may allow theholder to have only minimal contact with the delivery suture assembly,such that the size and surface area of the holder can be reduced.

In some embodiments, the delivery suture assembly can be deployed to agraft without the use of a removable holder. In such embodiments, thewindings of the delivery suture assembly (with or without the anchorsuture) may be configured so as to maintain a configuration that canallow them to be positioned over the graft. For example, the windingscan have “open” configuration such that the delivery suture assembly canbe easily applied to the graft to subsequently be secured thereon.Various techniques may be used to prepare the delivery suture assemblysuch that it can be delivered to a graft without a separate holder. Forexample, prior to being deployed, the delivery suture assembly can bereinforced using a suitable material such as, e.g., biocompatiblecoatings, wax of any suitable type, surgical glue or any other suitablematerial that can be used to stiffen the suture windings such that theymaintain a configuration suitable for receiving a graft through thewindings.

Referring back to FIG. 2, the configuration of the holder can bechangeable such that a user (e.g., a surgeon or other medicalprofessional) can manipulate the holder to separate it from the deliverysuture assembly removably associated therewith. Furthermore, the holder202 can have suitable structural features that enhance its function ofdelivering the delivery suture assembly to a graft. For example, theouter surface of the holder 202 can have one or more features thatfacilitate coupling of the anchor suture and/or the spine thereto. Inone embodiment, the holder can have a feature that allows maintainingthe anchor suture at an end of the holder.

As shown in FIG. 2, the spine 206 can be positioned along a length ofthe holder 202, such as along the outer surface 217 thereof. In theexample of FIG. 2, the outer surface 217 can be an outer wall whichcircumscribes an arc in a range of about 180° to 360°. A person skilledin the art will appreciate that the spine 206 can have any suitablelength. For example, in the embodiment illustrated in FIG. 2, the spine206 extends beyond the holder 202; however, the spine 206 can have thesame length as the holder 202 or it can be shorter than a longitudinallength or other dimension of the holder 202. The length of the spine 206can be selected such that the spine 206 can support a desired number ofsuture windings while adequately distributing load among the windingsand eventually along a portion of the graft.

The spine 206 can have associated therewith attachment elements216A-216D, which, in the example of FIG. 2, are longitudinally spacedalong the spine 206 between first and second ends 209, 211 thereof. Theattachment elements 216A-216D can be eyelets, which can be formedintegrally with the spine 206—for example, from the same suture that isused to form the spine 206, as discussed in more detail below. As usedherein, an “eyelet” can be an opening formed by a loop of the suture, oran opening formed through the suture by penetrating therethrough. Insome embodiments, the spine can be formed using crocheting or othertechnique thereby the spine can have eyelet formed therein. The spinecan be formed using a suitable suture material. In some embodiments,however, the spine may be formed from different types of material(s),including materials that are typically not used for sutures.

The opening can have any suitable size and shape, and can be formed inany suitable manner. It should be appreciated that other types ofattachment elements can be associated with the spine 206, as embodimentsare not limited in this respect. The attachment elements 216A-216D canall be of the same type (e.g., eyelets). Alternatively, in someembodiments, one or more of the attachment elements 216A-216D can be ofa type that is different from that of other attachment elements.Furthermore, four attachment elements 216A-216D are shown by way ofexample only, as any suitable number of attachment elements can be used.In addition, the suture 212 and the anchor suture 208 can simply bepassed through the spine 206, in an embodiment of a spine that does notinclude attachment elements.

As further shown in FIG. 2, both the anchor suture 208 and the suture212 can be coupled to the spine 206 via the attachment element 216A thatis adjacent the first end 209 of the spine. The attachment element 216Acan be, for example, an eyelet. The eyelet can be formed integrally withthe spine 206, or in some other suitable manner.

The anchor suture 208, which is used to anchor the spine 206 to thegraft at a desired location, can be coupled to the spine 206 by passingit through an eyelet or in any other manner. In one embodiment, theanchor suture 208 can be secured adjacent the first end 209 of the spine206, which is at a location that will be spaced away from a terminal endof a graft.

The anchor suture used to position and affix the suture windings aroundthe graft in accordance with the described embodiments may be of anysuitable type. For example, in some embodiments, rather than using aseparate suture as the anchor suture, the anchor suture may be anextension of the spine. In such embodiments, the anchor suture may betrimmed to a suitable length after it is used to position the deliverysuture assembly around the graft. The extension of the spine may be asingle strand or, in some embodiments, it may be bifurcated into twostands or separated into more than two strands beyond the first end 209of the spine. The anchor suture that is an extension of the spine may beformed integrally with the spine (and the suture or other elementforming the spine can be, in some cases, separated into two or morestrands that can serve as the anchor suture) or it may be a separatesuture nonremovably coupled with the spine.

The anchor suture 208 can be configured to form a collapsible loop, orsnare, 208A that surrounds the holder 202 prior to deployment of thedelivery suture assembly 204. The loop 208A can be any form of aself-tightening knot and it can be formed in any suitable manner. Whenthe delivery suture assembly 204 is deployed, the loop 208A can beremoved from the holder 202, and the holder can be removed as well. Theloop 208A and the anchor suture 208 can then be used to affix, oranchor, the spine 206 to a ligament graft. A tail 213 of the anchorsuture 208 can be used to cause the loop 208A to collapse to therebyaffix the anchor suture 208 to the graft.

It should be appreciated that the described techniques are not limitedto any specific type of an anchor suture. Thus, in some embodiments, theanchor suture may be formed integrally with the spine—e.g., from thesame suture or other element that is used to form the spine.Furthermore, in some cases, the anchor suture may not be used at all.

The windings 210A-210G formed from the suture 212 can be coupled to thespine 206 via the attachment elements 216A-216D longitudinally spacedalong the spine 206. As shown in FIG. 2, the attachment element 216D ispositioned at the second end 211 of the spine 206, opposite to theattachment element 216A positioned at the first end 209 of the spine206. The second end 211 of the spine 206 will typically be positionedadjacent to a terminal end of a graft. As shown in FIG. 2, theattachment element 216A can be used to couple both the anchor suture 208and the suture 212 to the spine 206. Each of the attachment elements216A-216D can be an eyelet (e.g., an eyelet formed integrally with thespine 206) having one or more windings passing therethrough, or othertype of an attachment element. For example, one or more separateelements can be used to couple the windings 210A-210G to the spine 206.

Regardless of the type of attachment elements utilized, the windings210A-210G can be formed by passing portions of the suture 212 havingrespective tails 214A, 214B through the attachment elements (or throughthe spine in the absence of attachment element) and around the holder202. As shown, the windings extend along a length of the holder 202 in acriss-cross like pattern. Each of the windings 210A-210G can form acollapsible loop that is associated with the holder 202 prior todeployment of the delivery suture assembly 204. In some embodiments, thewinding 210A positioned adjacent the end 209 of the spine 206 can act asa reinforcing winding additionally formed to improve the strength ofattachment of the assembly to the graft.

It should be appreciated that the four attachment elements 216A-216D areshown in FIG. 2 as an example only, as any other number of attachmentelements can be used for coupling any suitable number of windings to thespine. For example, in some embodiments, one or more of the attachmentelements 216B-216D can include two attachment elements. In such anembodiment, one or more of the windings 210C-210G can be coupled to thespine 206 at respective close, but separate, locations along the spine206. For example, the windings 210C and 210D can each be coupled to thespine 206 via a separate attachment element (e.g., an eyelet) locatedclose to each other such that these attachment elements are shown as thesingle attachment element 216B in FIG. 2. The winding 210B can also becoupled to the spine 206 via an attachment element separate from theattachment element 216A. It should be appreciated, however, that,regardless of a number and type of attachment elements or locations atwhich the suture 212 forming the windings 210A-210G is passed throughthe spine, the windings 210A-210G can be coupled to the spine 206 suchthat they are approximately evenly distributed around the spine 206 andlater around a graft.

Furthermore, in some embodiments, the windings 210 can be formed fromthe same suture or other element forming the spine. For example, thespine can be extended and bifurcated beyond the first end 209 thereofinto two separate sutures, or strands, which can be used instead of thesuture 212. As discussed above, in some embodiments, the anchor suturecan also be formed as an extension of the spine. Thus, in someembodiments, both the windings and the anchor suture may be formed fromthe same element as the spine.

As shown in FIG. 2, the tails 214A and 214B of the suture 212 can extendfrom the second end 211 of the spine 206 opposite to the first end 209thereof that is coupled to the anchor suture 208. The tails 214A and214B can be manipulated when the delivery suture assembly 204 isdeployed to affix the windings 210A-210G to the graft.

FIGS. 3A-3E illustrate an exemplary embodiment of forming a deliverysuture assembly (e.g., the delivery suture assembly 204 in FIG. 2). Asshown in FIG. 3A, first, a suture 300 can be threaded into itself in adirection shown with an arrow 301 to thereby form a loop, or an eyelet,304 and a spine 302 (e.g., the spine 206 of FIG. 2). The eyelet 304,shown as formed adjacent an end 305A of the spine 302, can serve as anattachment element, such as the attachment element 216A (FIG. 2). Thesuture 300 can be threaded into itself using any suitable techniqueknown to those skilled in the art. A thickness of the suture 300 can beselected such that a portion of the suture can be threaded throughanother portion thereof without compromising the suture strength. Forexample, an end of the suture 300 can be guided (using a needle or otherappropriate tool) in the direction 301 to leave a loop forming theeyelet 304 and to then pull the suture 300 back therethrough. A portionof the thus threaded suture 300 extending from the eyelet 304 can formthe spine 302, which can have any suitable length. For example, in someembodiments, the spine 302 can have a length of at least about 30millimeters (mm).

Next, as shown in FIG. 3B, a first suture 306 can be passed through theeyelet 304 in a direction shown by an arrow 308. This can be a suture(e.g., the anchor suture 208 of FIG. 2) configured to act as acounter-tensioning suture that anchors the delivery suture assembly tothe graft. The first suture 306 can be positioned to extend away fromboth ends 305A and 305 B of the spine 302, as shown in FIG. 3B.

A second suture 310 can be passed through the eyelet 304 in a directionindicated by an arrow 312 in FIG. 3C. The suture 310 can be passedthrough the eyelet 304 such that a portion 311 of the suture 310 locatedapproximately in the middle thereof is at least partially positionedwithin the eyelet 304. In this way, the suture 310 can be separated intotwo portions having respective free ends, or tails, 314 and 316 that canextend from the eyelet 304 as shown in FIG. 3C. The suture 310 can thenbe used to form windings, such as windings 210A-210G in FIG. 2, bypassing tails 314 and 316 through the attachment elements and around aholder (not shown) in a criss-cross pattern to form the structure shownin FIG. 2 and as explained below. In this way, the eyelet 304 can beused to couple both sutures 306 and 310 to the spine 302. In oneembodiment, a length of the suture 310 can be about 36 inches. However,it should be appreciated that the suture 310 can have any suitablelength as embodiments are not limited in this respect.

The suture 306, which is also referred to herein as an anchor suture,can be manipulated to form a loop, or snare, comprising aself-tightening knot. The snare can be formed in any suitable manner andcan be a collapsible loop that is capable of collapsing to form a knotwhen a tail of the loop is pulled. The snare can alternatively oradditionally be a sliding knot, such as, for example, any type of knotwell known to those skilled in the art. Any other sliding knots can beused as well. As schematically shown in FIG. 3C, the suture 306 can bepassed through the eyelet 304 in a direction of an arrow 315 to form oneor more loops (not shown) which can form the snare.

Sutures comprising any suitable materials can be used for the describedgraft preparation techniques. In some embodiments, the anchor suture306, the suture 310 forming the windings, and the suture 300 forming thespine can comprise various surgical sutures, typically size 0 to size 5,such as Orthocord™ suture commercially available from DePuy Mitek, andEthibond™ suture available from Ethicon. Orthocord™ suture isapproximately fifty-five to sixty-five percent PDS™ polydioxanone, whichis bioabsorbable, and the remaining percent ultra high molecular weightpolyethylene, while Ethibond™ suture is primarily high strengthpolyester. The sutures can also comprise High-Molecular Weight (HMW)polyethylene sutures or HMW polyethylene sutures with a co-braid (e.g.,monofilament polypropylene, nylon or other co-braid). In someembodiments, monofilament sutures such as, for example, Monocryl®available from Ethicon, may be utilized. As another example, anabsorbable suture such as Vycryl® (a copolymer made from 90% glycolideand 10% L-lactide) also available from Ethicon may be used. The sutures300, 306 and 310 can comprise any suitable amount and type ofbioabsorbable material, which can depend on a particular surgicalprocedure and/or surgeon preferences.

The suture 300 can have a thickness and structure appropriate for aportion of it to be threaded through the suture itself. The sutures 300,306 and 310 can comprise multiple threads that can be combined in asuitable manner to (e.g., using braiding, weaving, knitting, entanglingand/or using any other technique) such that the suture has sufficientstrength and a structural integrity of the suture is maintained even ifit is penetrated.

In some embodiments, after one or both of the sutures 306 and 310 arepassed through the eyelet 304, the eyelet 304 can be tightened aroundthe suture(s) in a suitable manner. For example, suitable graftpreparation or other type of equipment can be used such that appropriatecomponents thereof are used to tighten the eyelet 304. It should beappreciated that embodiments are not limited to any specific techniquethat can be used to tighten the eyelet 304. Although not drawn to scale,FIGS. 3A-3E illustrate schematically that the eyelet 304 can betightened—a loop forming the eyelet 304 in FIGS. 3A and 3B is wider thanthe eyelet 304 in FIGS. 3C-3E after the eyelet 304 has been tightened.It should be appreciated that, in some embodiments, the eyelet 304 canbe tightened before either of the sutures 306 and 310 is passedtherethrough.

In some embodiments, markings 318-318D, shown in FIG. 3D can next beapplied to the spine 302 formed from the suture 300 to visually identifysites at which the windings are to be coupled to the spine 302. Thefirst marking 318 can be applied adjacent to the eyelet 304 at the end305A of the spine 302. Alternatively, the marking 318 can be omitted.The markings 318A-318C, which identify locations at which the suture 310is to be coupled (e.g., passed through or otherwise coupled) with thespine 302, can be longitudinally spaced along the spine 302 between theends 305A and 305B thereof and can be formed at a suitable distance fromthe eyelet 304. In one embodiment, the markings 318A-318C can be equallyor approximately equally spaced along a length of the spine 302.However, it should be appreciated that the markings 318A-318C can bespaced apart in any other manner, as the described techniques are notlimited in this respect.

In one embodiment, a distance d between the marking 318 adjacent theeyelet 304 and the marking 318C that is formed adjacent the end 305B canbe about 30 millimeters (mm), and all of the markings 318-318C can bespaced about 10 mm apart from each other. It should be appreciated,however, that the markings 318-318C that are spaced apart from eachother at about equal distances are shown by way of example only, as themarkings can be spaced apart from each other at any other distances,including different distances. The distances between the markings318-318C can be selected based on a type of the graft, patient'scharacteristics, type of a reconstruction procedure, and any otherfactors. Furthermore, in some embodiments, the markings may be omittedaltogether, or only some of them can be applied. Any others techniquesmay be used to identify sites of coupling the windings to the spine 302.As another variation, in some embodiments, the markings may be appliedbefore one or both of the sutures 306 and 310 are coupled to the spine302 via the eyelet 304.

Regardless of the way in which locations for coupling windings to thespine 302 are identified along the length thereof, the suture 310 canthen be manipulated such that one of its tails, for example, the tail314, is passed through the spine 302 to create windings to be lateraffixed to the graft. For this purpose, a needle or other suture passinginstrument (not shown) can be passed through the suture 310 and used toguide the tail 314 of the suture 310 to penetrate through the spine 302.As shown in FIG. 3E, the suture 310 can be threaded through the spine302 by first passing, in the direction of an arrow 320—from the top tobottom, through the spine 302, at a location thereof identified by themarking 318A or in other manner. The needle can penetrate through thespine 302 via an eyelet 322A, which can be a portion of the spine or, insome embodiments, another attachment element using to couple a windingto the spine. After the suture 310 is pulled through the eyelet 322A, aportion of the suture 310 can be left loose such that a loop 324A iscreated. The length of this portion can be selected based on a desiredsize of a winding being created in this manner. FIG. 3E showsschematically a diameter l of the loop 324A, or a distance between thespine 302 and a widest portion of the loop 324A, which defines thediameter of the winding.

Next, the suture 310 can be passed around the spine 302 (as shown withan arrow 321) and, in a manner similar to the above, can be guided topass through the spine 302 at the location of the marking 318B tothereby form another eyelet 322B. The suture 310 can be passed in thesame way as it was passed through the eyelet 322A—from the top of thespine 302 to the bottom. However, it should be appreciated that thesuture 310 can pass the spine 302 in the opposite direction as well.

After being passed through the eyelet 322B, a portion of the suture 310can again be left loose to thereby form a loop 324B. A diameter of theloop 324B can be approximately the same as the diameter d₁ of the loop324A. As a next step, the needle can be used to guide the suture 310 topenetrate through the spine 302 at the location identified by themarking 318C, to form an eyelet 322C. A portion of the tail 314 canextend from the loop 324C to be later used for tensioning the windingsaround the graft.

Although not shown in FIG. 3E, the suture 310 can next be passed oncethrough the eyelet 304 (e.g., to form the winding 210A in FIG. 2) andthe process above can be repeated for the portion of the suture 310having the tail 316. For example, the needle or another suitable tool isused to guide the suture 310 by the tail 316 to be sequentially passedthrough the spine 302 through eyelets 322A, 322B and 322C, in thedirection shown by the arrow 320—i.e., from the top to bottom, leavingloose portions of the suture 310 behind. Another set of loops similar tothe loops 324A-324C can thus be formed from the suture 310. In this way,the windings, such as the windings 210A-210G of the delivery sutureassembly 204 of FIG. 2, can be formed.

Regardless of the way in which the anchor suture and the plurality ofsuture windings coupled to the spine are formed, the resultingpre-assembled delivery suture assembly including the spine 302, theanchor suture 306 and the windings made as described above in connectionwith FIGS. 3A-3E can be coupled with a suitable component configured toprovide the delivery suture assembly to a graft. The component can be aholder, such as the holder 202 shown in FIG. 2, although a component ofany other type can be utilized additionally or alternatively. Thedelivery suture assembly can be coupled with the holder by passing theholder through the windings formed from the suture 310 and the loop orsnare formed from the anchor suture 306 and positioning the spine 302along a length of the holder.

It should be appreciated that the described techniques are not limitedto any particular way in which the windings can be formed from a suture.For example, in some embodiments, rather than passing the suture 310through the eyelet 304 (or securing it to an end of the spine in othermanner) and then passing its portions having tails 314 and 316 throughthe spine 302 starting from the attachment element 322A, the suture 310may not be passed through the eyelet 304 as the first step. Instead, asshown in FIGS. 3F-3M, a suture 310′ can be passed through a spine 302′(or otherwise coupled thereto) starting from an opposite end 305B′towards an end 305A′thereof such that the suture 310′ is passed throughan eyelet 304′ after one set of windings is created. Then, once itreaches the proximity of an eyelet 304′, the suture 310′ can be passedthrough the eyelet and another set of windings can be created by nowpassing the suture 310′ through the spine 302′ (or otherwise coupledthereto) in the opposite direction, from the end 305A′ towards the end305B′, to thereby create another set of windings.

In the example illustrated in connection with FIGS. 3F-3M, the spine302′ has been formed (e.g., as shown above for the spine 302 or in anyother manner) and the eyelet 304′ has been formed (in this example,integrally with the spine). Also, a suture 306′ serving as an anchorsuture has been passed through the eyelet 304′, which has been tightenedaround that suture, and two portions of the suture 306′ may be heldusing a graft preparation instrument during the process of making adelivery suture assembly.

As shown in FIG. 3F, using a needle 340 or other suture passinginstrument, the suture 310′ can be first passed through the spine 302′at a location of a marking 318C′. Similar to the manner of marking thespine 302 (as shown in FIGS. 3D and 3E), locations at which windings areto be coupled to the spine 302′ may be identified by markings318′-318C′. It should be appreciated, however, that the markings318′-318C′ are described by way of example only, as any other ways ofidentifying locations on the spine 302′ to couple windings thereto canbe used. Further, in some embodiments, the spine 302′ can haveattachment elements (e.g., eyelets, other types of openings, or anyother attachment elements) which may additionally or alternatively beused to couple the windings to the spine. Thus, although only themarkings 318′-318C′ are shown in FIGS. 3F-3L for the sake of simplicity,it should be appreciated that the locations at which windings324A′-324C′ are coupled to the spine 302′ may be identified in any othersuitable manner, including without using any markings.

As shown in FIG. 3F, the needle 340 can be used to pass the suture 310′through the spine 302′ from the top to the bottom, in a direction shownby an arrow 341 (other directions can be used instead), leaving a looseloop which can create the winding 324C′ as shown in FIG. 3G. FIG. 3Hillustrates that the suture 310′ can then be passed through the spine302′ at a location identified by a marking 318B′ which is closer to theend 305A′ of the spine 302′, again in the same direction—in thisexample, from the top to the bottom, leaving a loop thus forming thewinding 324B′ as shown in FIG. 31. Next, the suture 310′ can be passedthrough the spine 302′ at a location identified by a marking 318A′ tocreate a windings 324A′ in the same manner as above.

As shown in FIG. 3J, the suture 310′ can next be brought around thespine 302′ and passed through the eyelet 304′ to thereby create a loop342 (FIG. 3K) which can act as an end of the windings assembly (e.g.,the loop forming the winding 210A in FIG. 2). The suture 310′ can thenbe passed back in the opposite direction, towards the end 305B′ of thespine 302′, by being coupled with the spine 302′ at a location 318A′ asshown in FIG. 3L, to create a winding 344, and then at the locations318B′ and 318C,′ each time creating a winding (not shown). The spine302′ having the windings collectively identified in FIG. 3M by anumerical reference 345 coupled thereto created as described above maythen be positioned around a holder 346 (e.g., the elongate member 202 inFIG. 2 or any other holder) configured to deliver the assembly to agraft. A final assembly 348 shown in FIG. 3M can have the same structureas the assembly 204 in FIG. 2 made as shown in FIGS. 3A-3E. It should beappreciated, however, that the windings in accordance with someembodiments can be created in other suitable ways. Furthermore, in someembodiments, the delivery suture assembly may be deployed without usinga holder.

FIGS. 4A and 4B illustrate alternative views of a delivery sutureassembly 400 formed in accordance with some embodiments, for example, asshown in connection with FIGS. 3A-3E. The delivery suture assembly 400can be coupled to a holder 402 which, in the example illustrated, is anelongate holder which can have a changeable configuration capable ofdelivering the assembly 400 to a graft. For the sake of simplicity, theanchor suture 306 is not shown in FIGS. 4A and 4B, and only the windingsformed from the suture 310 are illustrated.

In FIG. 4A, the assembly 400 is shown such that the spine 302 isvisible. A plurality of windings 406A-406G formed from the suture 310can be coupled with the spine 302 via attachment elements 408A-408G. Thewindings 406A-406G can be formed by loops, some of which are shown inFIG. 3E as loops 324A-324C. In this example, each of the windings406A-406G is coupled with the spine 302 via a respective separateattachment element 408A-408G, one or more of which can be eyelets formedintegrally with the spine. However, in some embodiments, the windingscan be coupled to the spine via other types of attachment elements,including separate attachment elements.

As shown in FIG. 4A, the windings 406A-406G can form criss-crossingpatterns 410A, 410B along an outer surface 403 of the holder 402. Thewindings formed in this way and coupled to the spine 302 allowdistributing the load across the graft in a more uniform manner.

FIG. 4B illustrates an alternative view of the delivery suture assembly400 where the spine 302 is not visible. FIG. 4B again shows that the406A-406G can form criss-crossing patterns 412A-412C along an outersurface 403 of the holder 402.

FIG. 5 illustrates schematically a ligament graft 500 that can beprepared in accordance with some embodiments. The graft can be obtainedeither from the patient with the diseased or damaged ligament(“autograft”) or from a donor (“allograft”). The graft 500 can includeone or more tendon strands or other type of grafts. The graft 500 can becleaned, sized and processed in other suitable ways prior to affixingsutures thereto in accordance with the described techniques.

As shown in FIG. 5, the graft 500 can have proximal and distal ends 502and 504. As used herein, the “proximal” end can be defined as an end ofthe graft 500 that is nearest surgeon's hands preparing the graft 500.The “distal” end can be defined as an opposite end of the graft 500which can be fixed using, for example, suitable graft preparationequipment. Alternatively, in some cases, the distal end 504 of the graft500 can remain attached to the donor site of obtaining the graft 500 sothat the graft 500 is prepared for the reconstruction surgery withoutbeing separated from that site.

FIGS. 6A-6E illustrate one embodiment of a method of delivering thegraft preparation system 600 to the graft 500 and affixing suture(s) ofthe delivery suture assembly 204 onto the graft. These steps are alsoillustrated in FIGS. 7A-7H which are described below. In FIGS. 7A-7H,the graft 500 is shown as attached (e.g., clamped by jaws 702, withoutpenetrating through the graft) at the distal end 504 thereof to a grafttensioning device 700. However, as mentioned above, in some embodiments,during the preparation of the graft 500 for a reconstruction surgery,the distal end 504 of the graft 500 can remain at the donor site fromwhich the graft 500 is being harvested. Further, it should beappreciated that the delivery suture assembly is shown in FIGS. 7A-7H asbeing positioned at a middle portion of the graft for illustrationpurposes only, as the sutures may be affixed to an end portion of thegraft.

FIG. 6A shows a graft preparation system 600 which is essentiallyidentical to the graft preparation system 200 shown in FIG. 2, which isreproduced in FIG. 6A for clarity of representation. The graftpreparation system 600 can have the same components as the graftpreparation system 200, which are not described again to avoidrepetition. In addition, not all of the components of the graftpreparation system 200 are labeled in FIG. 6A.

FIG. 7A illustrates another view of the graft 500 and the holder 202positioned over the graft 500 and having the delivery suture assembly204 removably associated therewith. In FIG. 7A, the holder 202 is heldover the graft 500 such that the position of the holder 202 can bechanged to determine an ultimate location at which the sutures are to beaffixed to the graft 500.

As shown in FIG. 6B, the graft preparation system 600 can be positionedaround a portion of the graft 500. The graft 500 can be received by theholder 202 in any suitable manner, which can depend from a configurationof the holder. For example, the graft 500 can be pushed through orpulled into the holder 202 or otherwise associated with the graftpreparation system 600. The graft preparation system 600 can bepositioned adjacent an end of the graft 500. In the example illustratedin FIGS. 6A-6E, the graft preparation system 600 is positioned over thegraft 500 adjacent the proximal end 502 thereof. However, both ends ofthe graft 500 are typically prepared for the ligament reconstructionprocedure. Accordingly, the end of the graft 500 being referred to as aproximal end when the sutures are being affixed thereto can be referredto as a distal end when the sutures are applied to the opposite end ofthe graft.

As mentioned above, the elongate holder 202 having a substantiallycylindrical cross-section is shown herein by way of example only, as aholder having other suitable configurations can be used to carry adelivery suture assembly in accordance with the described techniques.Regardless of a type of the holder used, once the graft preparationsystem 600 is associated with the graft 500, the holder can bemanipulated (e.g., to change a configuration thereof or otherwisemanipulate it) such that the delivery suture assembly separates from theholder. In the example shown in FIG. 6C, the holder 202 is pulled outfrom under the snare 208A formed by the anchor suture 208 and thewindings 210 in a direction shown by an arrow 602, towards the proximalend 502 of the graft 500.

The holder 202 can have a configuration that allows one to manipulatethe holder to change that configuration to thereby position the deliverysuture assembly 204 around the graft 500. For example, the holder 202can be made from a flexible material and can be pinched or otherwisedeformed such that the delivery suture assembly 204 slides therefrom.FIGS. 7B-7D illustrate that the user can move the holder 202 whileholding the anchor suture 208 to thereby separate the delivery sutureassembly from the holder 202.

Accordingly, the holder 202 can be manipulated to be separated from thegraft 500 whereas the delivery suture assembly 204 can remain positionedaround the graft 500, as shown in FIG. 6C. As shown in FIG. 7E, afterthe holder 202 is withdrawn, the anchor suture 208 and windings 210 ofthe delivery suture assembly 204 remaining on the graft 500 can be looseloops positioned around the graft.

As illustrated in FIG. 6D, the tail 213 of the anchor suture 208 can bemanipulated—e.g., pulled in a direction of an arrow 604 towards thedistal end 504 of the graft 500 such that the pre-tied self-tighteningsnare 208A formed from the anchor suture 208 is tightened around thegraft 500.

It should be appreciated that, in some embodiments, the anchor suture208 can be separated from the holder 202 while at least a portion of theholder 202 is still associated with the graft 500 and at least some ofthe windings remain on the holder. In such embodiments, the tail 213 ofthe anchor suture 208 can be manipulated to affix the anchor suture 208to the graft 500 prior to separating the delivery suture assembly 204from the holder 202. As shown in FIG. 7B, the anchor suture 208 can bepulled away from the holder 202 to cause the self-tightening snare 208Ato slide off the holder 202 as illustrated in FIG. 7C. This causes thesnare 208A to self-tighten and to thereby become affixed around thegraft 500, as shown in FIG. 7D where the snare 208A is positioned aroundthe graft 500 while the holder 202 is held around the graft 500. Thetightening of the snare 208A around the graft 500 anchors the locationof the delivery suture assembly 204 on the graft 500.

As shown in FIG. 7F, after the anchor suture 208 is used to position thedelivery suture assembly 204 around the graft 500 using the snare 208A,the delivery suture assembly 204 can be separated from the holder 202.The windings 210 can form loose loops around the graft 500 after theholder 202 is removed, as shown in FIG. 7E.

Next, after the self-tightening snare 208A is affixed around the graft500 and the holder 202 is separated therefrom, the tails 214A, 214B ofthe windings 210 can be manipulated to tighten the loose loops thereofaround the graft 500 as shown by arrows 608A-608C in FIG. 6E. Forexample, the tails 214A, 214B can be pulled in a direction of an arrow606 which can be opposite to the direction of 604 at which the tail 213of the anchor suture 208 was pulled. FIGS. 7F and 7G similarlyillustrate that the tails 214A, 214B can be pulled to affix the suture212 to the graft 500, with FIG. 7F illustrating a beginning of theprocess of manipulating the tails 214A, 214B when the windings 210 stillform the loose loops around the graft. FIG. 7G illustrates a later stageof the process at which some of the windings 210 no longer form looseloops and instead are affixed to the graft 500 to compress the surfacethereof.

The tails 214A and 214B can be pulled in an alternating fashion, suchthat the windings formed by the respective portions of the suture 212are tightened in an alternating manner. However, the tails 214A, 214Bcan alternatively or additionally be pulled simultaneously, asembodiments are not limited to a specific way of manipulating the tails214A, 214B to secure the windings 210 around the graft.

The tails 214A and 214B can be pulled while applying counter tension tothe spine 206 which causes the windings 210 to cinch thereon and aroundthe graft. The windings 210 can be secured around the graft such thatthey are evenly distributed around a portion of the graft and canthereby compress the graft with an approximately uniform force, whichcan prevent strangulation of the graft when the load is applied. Thespine 206 can help to maintain appropriate spacing between the windings210, which can increase contact of the suture 212 with the surface ofthe graft 500 and may ultimately improve the strength of fixation of thegraft 500 to the reconstruction site. Furthermore, because of the moreuniform distribution of the load among the windings, as compared toconventional approaches, elongation of the graft when the load isapplied thereto can be decreased. In addition, the risk of graft fiberseparation, pull-through or fraying of the graft can be reduced. FIG. 7Hillustrates a final step of tightening the tails 214A, 214B toappropriately secure the windings 210 to the graft 500.

In some embodiments, after the windings 210 are affixed to the graft,the anchor suture 208 can be removed from the graft (e.g., cut off usingan appropriate instrument). In some embodiments, alternatively oradditionally, the spine 206 can be removed from the spine—for example,cut off using an appropriate instrument. However, in other embodiments,either or both the anchor suture and the spine can remain affixed to thegraft when the graft is fixated in place (e.g., in the tunnels duringthe ACL reconstruction surgery).

As discussed above, the described techniques may utilize any suitabletype of a holder configured to deliver the delivery suture assembly to agraft. FIGS. 8A-8C illustrate an embodiment including a holderconfigured as a card-like structure having a generally rectangularconfiguration. As shown in FIG. 8A, a delivery suture assembly 800 caninclude a spine 802 and a plurality of windings 804 coupled thereto. Thewindings 804, which may be formed from a suture 805 or other type ofmaterial, can be coupled to the spine 802 in a variety of differentways. For example, each of the windings 804 may be coupled to the spine802 or only some of the windings may be coupled to the spine 802. Theportions of the windings 804 coupled to the spine 802 are labeled inFIG. 8A as elements 804A and 804B by way of example only. The spine 802may be formed from a suture or from other (non-suture) type of material.

As shown in FIG. 8A, the spine 802 and the windings 804 can be coupledto a holder 806 configured to provide the delivery suture assembly 800to a graft 808 schematically illustrated in FIG. 8A. The holder 806 maybe a substantially rectangular element such that it is configured as acard having two portions 806A, 806B connected via a hinge portion 806Cwhich can move from an open or partially open configuration (FIG. 8A) toa closed configuration (FIG. 8B) by pivoting the portions 806A, 806Baround the hinge 806C (e.g., a fold). As used herein, a “substantiallyrectangular” can be defined as being generally formed as a rectangle(e.g., as viewed from a side) such that the opposite sides of therectangle may not be exactly parallel or may not have the exact samelength. Also, the corners of the element may be rounded off or shapedotherwise.

In this embodiment, the windings 804 can be coupled to the holder 806such that a portion 807 of the windings 804 forming criss-crossingpatterns is disposed on an inner surface 809 of the holder 806. Thesuture 805 forming the windings 804 can be coupled with the holder 806by penetrating the holder 806 at locations 810A-810C (in the portion806A) and 812A-812C (in the portion 806B) such that portions of thesuture 805 are positioned on an outer surface 811 of the holder 806. Itshould be appreciated that three locations 810A-810C and 812A-812C ateach of the portions 806A, 806B are shown as an example only, as thewindings 804 can be coupled to the holder 806 in any other manner. Forexample, the holder 806 can have a suitable number of attachmentelements for coupling the windings therewith. Furthermore, the holder806 can have a configuration different from that shown in FIGS. 8A-8C.

The spine 802 can be coupled to the holder 806 by virtue of the suture805 being coupled to the holder 806. Alternatively or additionally, thespine 802 can be coupled to the holder 806 in a suitable manner (e.g.,using suitable attachment elements).

In use, as shown in FIG. 8B, the holder 806 can be positioned over thegraft 808 such that the windings 804 (not visible in FIG. 8B) surroundthe graft 808. To position the delivery suture assembly 800 around thegraft, the holder 806 can be moved from the open configuration (FIG. 8A)to a closed configuration (FIG. 8B). Tails 805A and 805B of the suture805 are visible in FIG. 8B.

After it is positioned around the graft 808, the delivery sutureassembly 800 can be separated from the holder 806 in a suitable manner.For example, the holder 806 can be made from a paper or other easilytearable material (such as a plastic film, for example) and the windings804 can be separated from the holder 806 by tearing the holder 804 suchthat tears 814A, 814B can be formed in portions 806A, 806B of the holder806. The holder 806 can then be removed, as shown in FIG. 8C. Thewindings 804 can be secured around the graft 808, for example, bymanipulating the tails 805A and 805B of the suture 805, to thereby formcriss-crossing patterns 816 around the graft 808 as shown in FIG. 8C. Itshould be appreciated that three criss-crossing patterns 816 are shownby way of example only, as any suitable number of windings configured toform any number of criss-crossing or other types of patterns can beutilized.

The delivery suture assembly 800 shown in FIGS. 8A-8B does not includean anchor suture. It should be appreciated, however, that the anchorsuture or other element configured to position the spine 802 and thewindings 804 coupled thereto on the graft may be included in thedelivery suture assembly 800.

In some embodiments, a delivery suture assembly in accordance with someembodiments may be provided to a graft without the use of a separateholder. Such an embodiment is illustrated in FIG. 9 showing a deliverysuture assembly 900 comprising a plurality of windings 902. The windings902, which may be coupled to a spine (not shown), can be positionedaround a grasper 904 or other surgical instrument that can be configuredto grasp a graft 906 by jaws 908 or other members coupled to a distalend of a shaft 912 of the grasper 904. The windings 902 can be preparedsuch that, rather than forming loose loops, they are maintained in astiffened, “open” configuration which may be achieved by coating thewindings using a suitable material such as, for example, biocompatiblecoatings, wax of any suitable type, surgical glue or any other suitablematerial that can be used to stiffen the suture windings such that theymaintain a configuration suitable for receiving a graft therethrough.The reinforced configuration of the windings and, in some embodiments,an anchor suture, may be temporary. For example, when the windings arepositioned around the graft, their reinforced configuration may bechanged to a more relaxed configuration such that the windings can betightened and thereby secured around the graft.

The windings 902 can be slid over or otherwise positioned around theshaft 912 of the grasper 904 to be delivered to the graft 906. When thegrasper 904 engages with the graft 906 (not shown), the windings 902 canbe moved distally (i.e., away from a proximal end 911 of the shaft 912)to thereby be positioned around the graft 906. The windings 902 can thenbe secured around the graft 906, as discussed above.

As discussed above, in some embodiments, a holder used to deliver adelivery suture assembly to a graft may have a configuration differentfrom that of a holder 202 shown, for example, in FIG. 2. FIGS. 10A-10Cillustrate an embodiment where a holder has a reduced surface area.

As shown in FIG. 10A, a delivery suture assembly 1000 including windings1002 may be positioned around a graft 1004 using a holder 1006. Ananchor suture or a similar member may or may not be present.

The holder 1006 can include a holder spine 1008 and two end portions1010 and 1012 formed at opposite ends of the holder spine 1008. As shownin FIGS. 10A and 10C, the end portions 1010 and 1012 can be arcuate andcan circumscribe an arc in a range of about 180° to 360°. It should beappreciated, however, that the portions 1010, 1012 can have othershapes. Moreover, in some embodiments, the portions 1010, 1012 can beomitted.

As shown in FIGS. 10A and 10C, the holder spine 1008, positioned alongan outer surface of the graft 1004, may have a relatively smallthickness and it is configured to couple the windings 1002 with theholder 1006. Accordingly, in this embodiment, the holder spine 1008 canprovide both the function of a suture spine (e.g., the spine 206 of FIG.2)—to maintain the windings 1002 spaced apart from each other, and thefunction of delivering the windings 1002 to a graft in a ready-to-deployconfiguration. In some embodiments, a suture spine can be used inconjunction with the holder 1006—for example, the suture spine can bedisposed along a length of the holder spine 1008. In some cases, thesuture spine can be omitted. The windings 1002 can be reinforced asdescribed above to maintain a configuration suitable for receiving agraft therein.

As in the embodiments discussed above, when the delivery suture assembly1000 is positioned around the graft 1004 using the holder 1006, thewindings 1002 can be separated from the holder 1006 such that theyremain positioned around the graft 1004. The windings 1002 can then besecured around the graft 1004, as schematically shown in FIG. 10B.

The holder 1006, which is shown in more detail in FIG. 10C, may includeone or more attachment elements 1014A-1014D formed in the holder spine1008. The attachment elements 1014A-1014D, which may be openings in thesurface of the holder spine 1008 or other types of attachment elements,may be spaced longitudinally along a length of the holder spine 1008. Toprepare the delivery suture assembly 1000, a suture 1003 forming thewindings 1002 can be passed through the attachment elements 1014A-1014Dto thereby couple the windings 1002 to the holder spine 1008.

As also shown in FIG. 10C, the holder 1006 may have other features thatcan maintain structural integrity of the holder and facilitatepositioning of the delivery suture assembly 1000 around the graft. Forexample, the holder 1006 can include optional members 1016, 1018, inthis example, each coupled with portions 1010 and 1012 as shown in FIG.10C. The members 1016 and 1018 can assist in coupling the windings 1002to the holder 1006 in a manner that can facilitate delivery of thewindings 1002 (and, in some embodiments, an anchor suture or othersimilar element) to the graft. For example, the members 1016, 1018 canhelp maintain the loops forming the windings in an open configuration.As shown in FIG. 10C, each of the portions 1010 and 1012 can include oneor more attachment elements such as the attachment elements 1020, 1022and 1024, 1026 which can be used to pass the suture 1003 therethrough orto otherwise couple the suture 1003 with the holder 1006. Additionallyor alternatively, an anchor suture can be passed through one or more ofthese attachment elements.

Although not shown in FIG. 10C, the members 1016, 1018 may have otherfeatures. For example, the holder 1006 can include more than twoelements similar to the members 1016, 1018. Further, in someembodiments, the members 1016, 1018 may be omitted. The attachmentelements 1020, 1022 and 1024, 1026 can be used to couple the suturesthereto or, in some cases, some or all of the attachment elements may beomitted as well.

The holder 1006, including optional members 1016, 1018, may be formedfrom a flexible material, such as plastic, fabric, metal foil, or anyother suitable material. The holder 1006 may have a changeableconfiguration such that the configuration may be changed to deliver thedelivery suture assembly 1000 to the graft. In addition, it should beappreciated that the holder 1006 described in connection with FIGS. 10Aand 10C is by way of example only, as the described embodiments canemploy a holder having any suitable configuration.

FIG. 11 illustrates a ligament graft 1100 prepared using the techniquesdescribed herein. In this example, two tendon strands 1102, 1104 may beused to replace a natural ligament. However, in some cases, grafts canbe tripled or quadrupled to more closely replicate the structure of thenatural ligament. It should be appreciated that any number of tendonstrands or other types of graft can be used, as the embodimentsdescribed herein may be used for preparation of any types of grafts.

As shown in FIG. 11, both ends of each of the strands 1102, 1104 can beprepared by affixing sutures thereto in accordance with someembodiments. Thus, each of the strands 1102, 1104 has respectivewindings 1106, 1108 and 1110, 1112 affixed thereto. Anchor sutures arenot shown in FIG. 11; however, it should be appreciated that, in someembodiments, the anchor sutures may be present on a prepared graft. Theresulting graft 1100 is prepared without penetrating therethrough, whichreduces a risk of damage of the graft during the reconstruction surgery.Furthermore, as described above, the graft 1100 can be prepared in anefficient and simple manner which can eliminate delays resulting fromaffixing sutures to grafts using conventional approaches.

In some embodiments, an anchor suture configured to lock a position of adelivery suture assembly around a graft may penetrate the graft foradditional strength of attachment. FIG. 12 illustrates such anembodiment where a delivery suture assembly 1200 may include a pluralitywindings collectively referred to as windings 1202 and an anchoringelement 1204 positioned around a graft 1206. In this example, thedelivery suture assembly 1200 has been separated from a holder 1208.

As shown in FIG. 12, the anchoring element 1204 (e.g., a suture or otherelement(s)) may penetrate the graft 1206 at a location 1210 and a tail1212 of the suture 1204 is shown in the opposite side of the graft 1206.It should be appreciated that the anchoring element 1204 may be passedthrough the graft 1206 in more than one location on the graft 1206.Also, additional loops, stitches or other techniques, not shown in FIG.12, may be used to affix the anchoring element 1204 to the graft 1206 tothereby help to secure the windings 1202 at a particular location aroundthe graft 1206.

It should be appreciated that although illustrated embodiments providetechniques for preparing anterior or posterior cruciate ligaments forligament reconstruction surgery, the techniques can be adapted forpreparation of other ligaments as well.

What is claimed is:
 1. A graft preparation system comprising: a spinehaving first and second ends; a plurality of windings formed from afirst suture and spaced longitudinally along the spine, each windingbeing coupled to the spine by passing the first suture throughattachment elements longitudinally spaced along the spine; and a second,anchor suture configured to position the spine and the plurality ofwindings coupled thereto around a graft, the anchor suture being coupledto the spine by passing through at least one of the attachment elementsadjacent to the first end of the spine.
 2. The graft preparation systemof claim 1, wherein at least one of the attachment elements comprises aneyelet formed in the spine.
 3. The graft preparation system of claim 2,wherein the eyelet is formed integrally with the spine.
 4. The graftpreparation system of claim 1, further comprising an elongate holderhaving a first surface and a second surface and configured to receivethe graft adjacent the second surface thereof.
 5. The graft preparationsystem of claim 4, wherein the spine is removably positioned along thefirst surface of the elongate holder.
 6. The graft preparation system ofclaim 4, wherein the anchor suture is configured to form a collapsibleloop surrounding the elongate holder and the anchor suture isselectively removable therefrom.
 7. The graft preparation system ofclaim 4, wherein the elongate holder has a configuration that can bechanged to separate the spine from the elongate holder.
 8. The graftpreparation system of claim 4, wherein the elongate holder issubstantially cylindrical in shape and the second surface is an innersurface.
 9. The graft preparation system of claim 4, wherein theelongate holder comprises a substantially rectangular element and thesecond surface is an inner surface.
 10. The graft preparation system ofclaim 4, wherein windings from the plurality of windings form acriss-crossing pattern along a surface of the elongate holder.
 11. Thegraft preparation system of claim 9, wherein at least one elementselected from the spine, the plurality of windings, and the anchorsuture is removably coupled with the elongate holder.
 12. The graftpreparation system of claim 1, wherein the anchor suture is configuredto form a snare comprising a self-tightening knot.
 13. The graftpreparation system of claim 1, wherein windings from the plurality ofwindings include first and second tails extending from the second end ofthe spine opposite to the first end of spine being coupled to the anchorsuture.
 14. The graft preparation system of claim 1, wherein the anchorsuture is formed integrally with the spine.
 15. The graft preparationsystem of claim 1, wherein the anchor suture is configured to penetratethrough the graft.